1. Field of the Invention
The present invention relates to an apparatus to detect and prevent the occurrence of sleep apnea, and a method of preventing the occurrence and continuation of sleep apnea related events. The present invention also detects, prevents and cures certain forms of arrhythmia and partial epilepsy.
2. Description of the Prior Art
Sleep Apnea is a breathing disorder that occurs during periods of sleep. The Greek word “apnea” means “without breath”. It is an intermittent cessation of ventilation during sleep that results in a decrease in blood oxygen levels, a decrease in heart rate, and resultant illnesses such as cardiac arrhythmias, hypertension, heart disease, and/or heart failure. The consequences of sleep apnea are evident throughout the waking hours, and include sleepiness, non-attentiveness, headaches, memory problems, weight gain, safety-related accidents, personality disturbances, and other sleep-deprivation related afflictions. The causes of the various forms of sleep apnea are not fully understood. There are three general types of sleep apnea: Obstructive, Central and Mixed.
Obstructive sleep apnea results from a blockage or occlusion of the oropharyngeal (upper) airway. With obstructive sleep apnea, respiratory functions continue, but blockage or occlusion of the airway results in reduced or halted airflow. The increased airflow resistance is typically caused by an anatomical or functional abnormality of the upper airway. These abnormalities have been known to include a displacement of the tongue during sleep, muscle disjunction in the upper airway dilator muscles, and excessive soft tissue in the neck that causes undue pressure on the airway structure (typically occurring in obese patients). Also, the act of snoring usually aggravates the narrowing of the upper airway through the production of edema in the soft tissues. Obstructive sleep apnea syndrome is indicated by a narrowing of the upper airway, resulting in a progressive asphyxia that continues until the individual is briefly woken from sleep, which restores airway patency and airflow through the upper airway. These frequent arousals, although necessary for proper airway ventilation to resume, deprive the individual from restorative deep sleep. These partial awakenings throughout sleep result in both mental and physical strain on the individual. Obstructive sleep apnea is the most common form of sleep apnea.
Central sleep apnea results from the brain failing to signal the muscles to breathe. The neural drive to the respiratory muscles discontinues for a brief period of time. These transients may continue throughout the night for periods from ten seconds to as long as 2 to 3 minutes. Central sleep apnea results from respiratory neuromuscular and metabolic control abnormalities or transient defects related to the respiratory control system. Often times individuals with central sleep apnea have a history of pulmonary hypertension, heart disease or heart failure, respiratory problems, or polycythemia. Central sleep apnea, similar to obstructive sleep apnea, causes a gradual asphyxiation during sleep, resulting is a brief arousal from sleep, at which time the individual's respiratory function returns to normal. Similar to obstructive sleep apnea, central sleep apnea can result in illnesses such as cardiac arrhythmias, hypertension, heart disease and/or heart failure. The consequences of central sleep apnea during the waking hours is similar to those of obstructive sleep apnea, and include sleepiness, non-attentiveness, headaches, memory problems, weight gain, safety-related accidents, personality disturbances, and other sleep-deprivation related afflictions.
Mixed sleep apnea is a combination of obstructive sleep apnea and central sleep apnea.
There are several known treatments for sleep apnea. They consist of physical or mechanical treatments, surgery, and attempts at pharmacological treatment. The treatment regimen is tailored to the individual, and is based on the medical profile of the patient being treated.
The most common effective treatment for patients with sleep apnea is nasal continuous positive airway pressure (CPAP). In this form of treatment, the patient wears a mask over the nose while sleeping. The mask is connected to a compressor that creates a positive pressure in the nasal passages. The continuous positive airway pressure system prevents the airway from closing or becoming obstructed during sleep. The air pressure from the continuous positive airway system is constant, and can be adjusted to best suit the individual's apnea condition. The air pressure in the continuous positive airway pressure system must be adjusted so that it maintains an open airway in the patient during all periods of sleep, but does not provide excessive pressure such that the device is bothersome to the patient. U.S. Pat. No. 4,655,213 discloses sleep apnea treatments based on the principles of continuous positive airway pressure. There have also been recent attempts at varying the applied pressure to increase the effectiveness of continuous positive airway pressure treatment. U.S. Pat. Nos. 4,773,411 and 6,539,940 disclose such techniques. The disclosures of these Unites States patents are incorporated herein by reference.
Continuous positive airway pressure systems remain the most effective treatment for sleep apnea. Many patients, however, cannot tolerate the positive airway pressure systems and associated apparatus. Common complaints include discomfort with the applied pressure, discomfort with the mask and equipment, nasal irritation, nasal stuffiness and congestion, airway dryness, mask air leaks and noise, noise of the CPAP machine, headaches, abdominal bloating, sore and irritated eyes, and an overall discomfort with the machinery. The noise and general obtrusiveness of the CPAP apparatus are often disruptive to another person sleeping with the user.
Another treatment for sleep apnea in certain patients involves the use of a dental appliance to reposition oral structures such as the tongue and the lower jaw. This form of treatment is typically performed by a dentist or dental specialist such as an orthodontist.
Surgery has also been performed to treat sleep apnea. In some surgical treatments, the size of the airway is increased. These surgical procedures contain elevated levels of risk in comparison to other treatment methods, and often times are not entirely effective. The form of surgery to be undertaken is specific to the patient and the patient's medical profile. The removal of obstructive tissue in the airway such as adenoids, tonsils or nasal polyps is a common form of surgical treatment for sleep apnea. The surgical correction of structural deformities is also a common form of surgical treatment for sleep apnea.
Another form of surgical treatment for sleep apnea is uvalopalatopharyngoplasty. This procedure removes excess tissue from the back of the throat, such as tonsils, uvula, and part of the soft palate. Somnoplasty is also being investigated as a possible treatment for sleep apnea. Somnoplasty uses radio waves to reduce the size of some airway structures such as the uvula and the back of the tongue.
Other forms of surgical intervention for sleep apnea include maxillo-facial reconstruction. Another form of surgical treatment for patients with severe and life threatening sleep apnea is Tracheostomy. This procedure involves making a small hole in the windpipe that accommodates a tube. The tube is opened only during sleep, and allows a patient to take air directly into the lungs, effectively bypassing any upper airway obstructions. Tracheostomy is an extreme procedure that is very rarely used except for cases of imminent life threatening sleep apnea.
Pharmacological treatments for sleep apnea have not generally been proven to be effective. Attempts at pharmacological treatment for sleep apnea have included respiratory stimulants such as theophylline, acetazolamide and medroxyprogesterone, and adenosine. Drugs that stimulate brain or central nervous system activity, such as naloxone and doxapram, have also been used in an attempt to treat sleep apnea. Other drugs that act on the neurotransmitters involved with respiration have also been used in an attempt to treat sleep apnea. These drugs include serotonin, dopamine, tryptophan, fluoxetine, and others. These pharmacological treatments for sleep apnea have not achieved any consistent levels of effectiveness, and often contain side effects.
Of the various treatments available for sleep apnea today, Continuous Positive Airway Pressure Systems have proven to be the most effective. Unfortunately, many patients cannot tolerate Continuous Positive Airway Pressure Systems. This leaves many sleep apnea patients without an effective treatment regimen.
There is therefore a need for a treatment for sleep apnea that does not involve the use of a complicated apparatus, and that does not include the use of pharmaceuticals.
Accordingly, embodiments of the present invention are provided that meet at least one or more of the following objects of the present invention. It is an object of this invention to provide an apparatus that detects and prevents the occurrence of sleep apnea, and also detects, prevents and cures certain forms of arrhythmia and partial epilepsy.
It is a further object of this invention to provide a method for treating sleep apnea, that reduces or eliminates the condition of sleep apnea in the patient.
It is a further object of this invention to provide an apparatus and a method for the monitoring and treatment of Sudden Infant Death Syndrome (SIDS).
It is a further object of this invention to provide an apparatus and a method for the treatment of snoring.